Country: United States
Language: English
Source: NLM (National Library of Medicine)
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)
Boiron
ORAL
OTC DRUG
Sleeplessness with hypersensitivity to stress* Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
unapproved homeopathic
VALERIANA OFFICINALIS- VALERIAN PELLET BOIRON _Disclaimer: This homeopathic product has not been evaluated by the Food and Drug_ _Administration for safety or efficacy. FDA is not aware of scientific evidence to support_ _homeopathy as effective._ ---------- VALERIANA OFFICINALIS 4X VALERIANA OFFICINALIS 4X (**contains 0.443 mg of the active ingredient per pellet) Sleeplessness with hypersensitivity to stress* Stop use and ask a doctor if symptoms persist for more than 3 days or worsen If pregnant or breast-feeding ask a health professional before use Keep out of reach of children Do not use if pellet dispenser seal is broken. Contains approx 80 pellets. How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details. lactose, sucrose Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor. 1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com Info@boiron.com Distributed by Boiron, Inc. Newtown Square, PA 19073 VALERIANA OFFICINALIS valerian pellet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:0220-5217 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 4 [hp_X] INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SUCROSE (UNII: C151H8M554) LACTOSE (UNII: J2B2A4N98G) PRODUCT CHARACTERISTICS COLOR white SCORE SHAPE ROUND SIZE 4mm FLAVOR IMPRINT CODE CONTAINS Boiron PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:0220-5217- 41 80 in 1 TUBE; Type 0: Not a Combination Product 03/03/1983 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START D Read the complete document